ZOLL Arrhythmia Management Sysyem

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

ZOLL Manufacturing Corporation

The following data is part of a premarket notification filed by Zoll Manufacturing Corporation with the FDA for Zoll Arrhythmia Management Sysyem.

Pre-market Notification Details

Device IDK190939
510k NumberK190939
Device Name:ZOLL Arrhythmia Management Sysyem
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh,  PA  15238
ContactZachary Nelson
CorrespondentMichael Nilo
Nilo Medical Consulting Group 5737 Kentucky Avenue #3 Pittsburgh,  PA  15232
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-10
Decision Date2019-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855778005364 K190939 000
00855778005357 K190939 000
00855778005463 K190939 000

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